Cadila CRO Presentation

8/3/2019 Cadila CRO Presentation

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Clinical Research

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Objective & Goals

Our Objective:

Taking life sciences to new horizons

through innovative research, high quality,ethics & commitment.

Our Goal:

To be a leading CRO in the world using committed

resources & to achieve 100% quality and

comp iance with good science, accurate techniques,prompt delivery and utmost Customer satisfaction.

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Cadila CRO Services

• Pre-clinical and toxicology studies.

• Bio-availability / Bio-equivalence studies.

• Bio-analysis

• Clinical Trial Management :

• Phase I – Safety Studies

• ase –

• Data Management

• Medical Writing

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• os a s cs



Salient Features of Existing Animal Unit.

• Total Area – 518 Sq.m with 8 Animal rooms & 1 Laboratory room.

• Double corridor facilit .

• Automated Illumination – 12 hr. lighting in 24 hours cycle.• 100% exhaust facility. No recirculation of air.

• Animal house walls painted with epoxy non-toxic washable paints.

• Species Propagated in-house breeding unit :

NZW Rabbits, Wistar Rats, Guinea Pigs, Swiss Albino Mice,

C57BL/6ByJ Mice, F1 C57 & DBA, DBA/2J Mice, BALB/C Mice

Accreditations :

a. DSIR Govt. of India.

b. ISO 9001 and ISO 14001.

c. Animal House is Registered With CPCSEA

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Pre Clinical and Toxicology ServicesWe have completed more than 780 studies and developed followingcapabilities in Toxicological studies.

– Single dose or multiple dose in single day, acute toxicity, acute eyeirritation and acute dermal irritation

– Repeated Dose, sub-acute (28 Days) and sub-chronic (90 Days)

– Special studies, genotoxicity, reproduction toxicity and toxicokinetics

– Allergenicity, Guinea pig maximization test (GPMT) and Mouse earswelling test (MEST)

– In Vivo Efficacy Studies, Antifertility test, Antidiabetic, Analgesics,Anti-hyper lipidemic and Pharmacokinetics.

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Pre Clinical Expertise

pec a stu es

• Genotoxicity

» Micro Nucleus Test (MNT)

» One generation• Toxicokinetics

Allergenicity

• Guinea pig maximization test (GPMT)

• Mouse ear swellin test MEST

In Vivo Efficacy Studies

• Antifertility test.

• Antidiabetic.• Analgesics.

• Anti-hyper lipidemic.

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In – House Pathology Laboratory

• The pathology laboratory is equipped with

¤ HITACHI-902 - biochemistry analyzer

¤ ADVIA-120 - haematology analyser

¤ CLINITEK STATUS - urine analyser

¤ Electrolyte analyser

• External quality control

programme for biochemistry.

• Well equipped histopathology

laboratory.

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Clinical Pharmacology Unit

• Two separate identical 46 bedded units (total 92 beds) with well equippedICUs.

Ca abilities

• o unteer ata poo o approx , ea t y vo unteers nc u ng

female volunteers and 400 geriatric volunteers database.

• Protocol development and Study designing.

• Conduct of a range of BA/ BE studies:

Fasting /Fed / Steady state studies.

¤ Dose proportionality and

erapeut c equ va ence stu es.¤ Open-labeled / blinded studies.

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, ,

Early phase exploratory vaccine trial, Drug interaction, female volunteers, and more….



Experience in BE

(conducted more than 209 BE studies)• Intravenous Anesthetic bioequivalence study, which involved Frequent sampling

every 2 minutes interval from each subjects and Critical care of each subject duringAE by Physician, Anesthetics and emergency equipments and drugs.

• Early phase exploratory vaccine trial on healthy volunteers.

• Conducted concurrently male and female volunteer studies

• Bioequivalence studies on large numbers of volunteers, n=80

-

– Drug-Drug interaction in new Fixed Dose Combination (FDC) compared withindividual reference products

– A novel POLYCAP (First time in the world a Fixed Dose Combination, , ,

coated Aspirin) compared with its single individual reference products to evaluategain or loss in bio-availability and drug-drug interaction in five different twoperiod two way cross over studies.

– -

Polycap study) study and has approved the concept of POLYCAP– Anti-retroviral and Anti-tubercular drug-drug interaction studies.

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Bio-Analytical Services

Features:

• Well equipped with latest detection methodologies.

• Instruments : LC-MS/MS, Automated HPLCs, UPLCs, Deep freezers,Refrigerated Centrifuges, N2 Evaporators,

asma extractors,

Milli Q-Water system.

• Team of 25 well qualified and

experienced scientists.

• A list of 91+ validated methodswhich are rugged and reproducible.

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Your advantage on Bio equivalence

ro ec me nes

o. o o un eers o. o er o s as ou er o s ra epor

24 2 1 week 1.5 months




• Timelines considered after the receipt of study drugs

• All study reports are as per ICH E3 guidelines

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CRO Regulatory Accomplishments

Accreditations & Certifications :

• DCGI certification for the BA/BE centre.

• Audited & approved by WHO Geneva

• Approved BA/BE faci ity by MoH, Tur ey.

• MCC South Africa - Certification for the Dossier submitted..

• - .

• TGA Australia – Dossier submitted & accepted.

• ANVISA, Brazil.

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Clinical Research ( Phase I – IV )

Cadila CRO offers complete package for conducting Phase I-IV Clinical Trials.

Unique Features:

• GCP trained Clinical Trial mana ement team.

• Robust experience in various therapeutic areas.

• Extensive network of hospitals and medical institutes through out India.

• Proficient Patient Recruitment strategy.

• Timely and scientific delivery of projects.

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Clinical Trial Services

Medical Writing & Protocol Development

– Protocol Development, designing of Screening form & CRF

– Expert review & reports of Safety data.

– a s ca na ys s an an epor .

– Regulatory Support.

Site Development & Management

– Investigator and Site Identification, selection, initiation, monitoring & contracts with Investigators andsite close outs

– Site staff and Investigator’s training

– Randomization, repackaging, coding & labeling of Investigational Products.

– Site Supplies.– Medical monitorin & uer mana ement.

Project Management & Site Monitoring

– Clinical development plan.

– Steering committee meetings.

– ra n ng eve opmen .

– Quality systems Implementation.

– GCP Audits at Investigators Site.

– SOP Management.

– Clean & locked data and corrective measures management.

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Therapeutic Expertise

• Oncology - (Phase 2 & 3)

• Endocrinology - (Phase 3 – Anti diabetic)

• Anti-infective - (Phase 3)

• ro ogy - ( ase

• CVS - (Phase 1, 2 & 3)

The Team also has experience in working in the following Therapeutic areas:

• GI - (Phase 3)• euma o ogy - ase

• Immunology - (Phase 1, 2 & 3)

• Neurology - (Phase 2 & 3)

• Dermatology - (Phase 3)

• Women’s Healthcare - (Phase 3)

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Data Management & Biostatistics

Soft wares :

• WinNonlin® Professional Version 5.0.1 (Pharsight Corporation, USA)

• SAS® Statistical Software Version 9.1.3 (SAS Institute Inc., USA )

• Automation of all trial activities by using Oracle Clinical 4.5.1 and

Thesaurus Management System 4.5.2

Related Services :

• Sample size determination, CRF designing, Patient Randomization, Querygeneration, resolution and tracking , Data Analysis, Transfer and Archiveand Generation of statistical report.

• Offers protocol review and Preparation of statistical Analysis Plan and

con uc s a s ca ana ys s or , rec n ca an n ca r a s

Compliance : ICH – GCP, Company’s SOPs and 21 CFR part 11

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Oncology Case Study on Efficient Patient Recruitment

Nov Dec an Feb Mar A r Ma un ul Au Se Oct NovNSCLC

08

08

09

09

09

09

09

09

09

09

09

09

09

Sites 8 8 8 17 17 17 17 17 17 17 17 17 17

Patients 24 47 59 17 105 136 162 220

24

220 total patients to be

recruited 47

No. of sites targeted 17 59

Strategy :

1. Govt. hospitals,

71

2. CRCs placed at

the site, 105

3. Non metro cities

targeted, 136

. x aust ve te

Staff Training, 162

220

Interim Analysis

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(77 Pts.)



Current Clinical Trials Experiences & Status

INDICATIONS SITESSAMPLE

SIZEREGULATORY STATUS

Erythropoietin Agent 4 101 DCGI Completed

Lipid Lowering 6 180 DCGI Completed

NSAIDS 6 320 DCGI Completed

Cardiovascular 55 2000 DCGI Being closed out

Anti Infective 8 120 DCGI Completed

Bladder Cancer-STCC 13 120 US FDA, DCGI Enrolling

Prostrate Cancer-HRPC 20 176 US FDA, DCGI Enrolling

Lung Cancer-NSCLC 17 220 US FDA, DCGI Recruitment completed

Bladder Cancer-STCC – BCG

Refractory14 20 US FDA, DCGI Enrolling

,

Pulmonary Tuberculosis

Category -12 600 US FDA, DCGI Active; recruiting patients

Pulmonary Tuberculosis

Cate or -27 1024 DCGI Enrollment completed

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Why Cadila CRO…

ecause we r ng oge er…• State of the art infrastructure.

• Highly competent team led by globally experienced and renownedscientists to ensure validit of all scientific work.

• High confidentiality standards.

• Utmost professionalism harmonizing with ethical practices.

• Strict adherence to GCP,GLP and in-house SOP’s.

• Rapid turn-around time.

• Strong commitment to responsiveness and timely delivery.

• Expert review & resolution of queries.• Excellent project management practices/tools backed by dynamic and

creative project tracking system.

• In depth Regulatory knowledge, support & expertise.

• .

• Large pool of volunteer databank enabling fast selection & recruitment.

• Respect to Client’s IPR

• Excellent track record.

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our re a e oca partner or g o a ontract esearc requ rements.

Dr. Sailendra Kumar Goswami

ce res en –

Cadila Pharmaceuticals Ltd. - CRO

[email protected]

Jasmeet Bagga

Business Develo ment – CRO

Cadila Pharmaceuticals Ltd. - [email protected]

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Cadila CRO Presentation

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